Pilot Trial of HMB for ALS
This study is testing a supplement called β-hydroxy-β-methylbutyrate (HMB) in 100 people with Amyotrophic Lateral Sclerosis (ALS). Researchers want to see if HMB is safe, well-tolerated, and can lower levels of a protein called IGFBP7 in the blood. They also want to see if HMB can slow down the progression of ALS symptoms, measured by the ALS Functional Rating Scale, Revised (ALSFRS-R) and speech changes. You may be able to join if you are at least 18 years old, have a diagnosis of ALS, and can read and write English. The study is considered successful if HMB is safe and shows signs of slowing ALS progression or lowering IGFBP7 levels. The current status of this study is unclear.
- Study design
- This is an open-label pilot study, meaning all participants will receive HMB and everyone will know what treatment they are getting. It plans to enroll 100 participants.
- What's involved
- You would participate for 9 months, with monthly phone calls and some in-person visits for blood draws and potentially spinal fluid draws if you enroll at Duke or Temple.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for the 9-month duration of the trial, with primary endpoints measured at baseline, month 3, and month 9.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Trial Utilizing β-hydroxy-β-methylbutyrate to Lower IGFBP7 Levels in People With ALS
At a glance
Conditions
NCT07589764
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Medical Center
Durham, North Carolinastudy coordinator listed
Temple University
Philadelphia, Pennsylvaniastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Richard Bedlack, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- ALS Functional Rating Scale, Revised (ALSFRS-R)Baseline, month 3, month 9
A quickly administered (five minute) ordinal rating scale (ratings 0-4) used to determine patients' assessments of their capability and independence in 12 functional activities. All 12 activities are relevant to people living with ALS.The ALSFRS-R declines linearly with time over a wide range during the course of ALS and it has been validated for telephone use. The ALSFRS-R Range is 0-48. The more points, the better the person is functioning.
- Speech (Listener Effort)Baseline, month 3, month 9
Listener effort (LE) is a perceptual rating of the amount of work necessary for a listener to understand speech, rated by an expert speech-language pathologist on a visual analog scale from 0 (easily understood) - 100 (unintelligible even with full effort) and it has proven to be one of the most robust overall measures of dysarthria.